search
Back to results

Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen
Placebo capsules, Letrozole, Anastrozole, Tamoxifen
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: The subjects voluntarily joined the study and signed the informed consent, with good compliance. Age: 18-75 years old (upon signing the informed consent); Eastern Cooperative Oncology Group Performance Status (PS) score: 0~1; Surgical treatment of radical mastectomy; Pathological examination confirmed HR positive and HER2 negative invasive breast cancer; The major organs are functioning well, meeting the following criteria： Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)： Hemoglobin (HB) ≥90 g/L； Neutrophil absolute value (NEUT) ≥ 1.5×109/L； Platelet count (PLT) ≥ 100 ×109/L； Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)： Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)； Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN； Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 ml/min； Blood clotting tests must meet the following criteria (no anticoagulant therapy)： Prothrombin time (PT) ≤ 1.5×ULN; Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; International Normalized ratio (INR) ≤ 1.5×ULN. Left ventricular ejection fraction (LVEF) ≥50%. Exclusion Criteria: Complicated diseases and medical history: Has had other malignant tumors within 5 years or currently has other malignant tumors; Have a variety of factors that affect oral medication (such as inability to swallow); Current history of serious lung disease such as interstitial pneumonia； Severe infections common terminology criteria for adverse events (≥CTCAE (common terminology criteria for adverse events) 2 grade) that were active or uncontrolled before the study treatment started (Except hair loss and hemoglobin)； Known allergy to aromatase inhibitors, tamoxifen, TQB3616/ placebo, or any excipients; There was a history of live attenuated vaccine vaccination within 28 days prior to randomization or live attenuated vaccine vaccination was planned during the study period; Participated in clinical trials of other antitumor agents within 4 weeks prior to randomization； The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of study participation or interfere with the study results, as well as subjects who are deemed unsuitable for study participation for other reasons by the investigator.

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical ScienceRecruiting
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Suining Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TQB3616 capsules combined with endocrine

placebo combined with endocrine

Arm Description

The dose of TQB3616 capsules is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle. The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.

The dose of placebo is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle. The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.

Outcomes

Primary Outcome Measures

Invasive Disease-Free Survival (IDFS)
The time from the date of randomization to the first occurrence of the following events, including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, secondary primary malignancy outside the breast, and death from any cause.

Secondary Outcome Measures

Overall survival (OS)
The time from first administration to death of any cause.
Disease Relapse Free Survival (DRFS)
The time from the date of randomization to the first occurrence of distant recurrence or death from any cause.
Incidence of adverse events
Incidence of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Severity of adverse events
Severity of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Incidence of abnormal laboratory test values
Incidence of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Severity of abnormal laboratory test values
Severity of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Incidence of serious adverse events
Incidence of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Severity of serious adverse events
Severity of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).

Full Information

First Posted
March 10, 2023
Last Updated
April 19, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05780567
Brief Title
Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
Official Title
Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1946 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB3616 capsules combined with endocrine
Arm Type
Experimental
Arm Description
The dose of TQB3616 capsules is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle. The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.
Arm Title
placebo combined with endocrine
Arm Type
Placebo Comparator
Arm Description
The dose of placebo is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle. The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.
Intervention Type
Drug
Intervention Name(s)
TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen
Intervention Description
TQB3616 is a novel Cyclin-dependent kinase (CDK) 4/6 inhibitor and currently being used in the treatment of a variety of malignant solid tumors. Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
Intervention Type
Drug
Intervention Name(s)
Placebo capsules, Letrozole, Anastrozole, Tamoxifen
Intervention Description
Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.
Primary Outcome Measure Information:
Title
Invasive Disease-Free Survival (IDFS)
Description
The time from the date of randomization to the first occurrence of the following events, including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, secondary primary malignancy outside the breast, and death from any cause.
Time Frame
Baseline up to 60 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
The time from first administration to death of any cause.
Time Frame
Baseline up to 60 months
Title
Disease Relapse Free Survival (DRFS)
Description
The time from the date of randomization to the first occurrence of distant recurrence or death from any cause.
Time Frame
Baseline up to 60 months
Title
Incidence of adverse events
Description
Incidence of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Time Frame
Baseline up to 60 months
Title
Severity of adverse events
Description
Severity of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Time Frame
Baseline up to 60 months
Title
Incidence of abnormal laboratory test values
Description
Incidence of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Time Frame
Baseline up to 60 months
Title
Severity of abnormal laboratory test values
Description
Severity of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Time Frame
Baseline up to 60 months
Title
Incidence of serious adverse events
Description
Incidence of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Time Frame
Baseline up to 60 months
Title
Severity of serious adverse events
Description
Severity of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Time Frame
Baseline up to 60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects voluntarily joined the study and signed the informed consent, with good compliance. Age: 18-75 years old (upon signing the informed consent); Eastern Cooperative Oncology Group Performance Status (PS) score: 0~1; Surgical treatment of radical mastectomy; Pathological examination confirmed HR positive and HER2 negative invasive breast cancer; The major organs are functioning well, meeting the following criteria： Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)： Hemoglobin (HB) ≥90 g/L； Neutrophil absolute value (NEUT) ≥ 1.5×109/L； Platelet count (PLT) ≥ 100 ×109/L； Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)： Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)； Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN； Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 ml/min； Blood clotting tests must meet the following criteria (no anticoagulant therapy)： Prothrombin time (PT) ≤ 1.5×ULN; Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; International Normalized ratio (INR) ≤ 1.5×ULN. Left ventricular ejection fraction (LVEF) ≥50%. Exclusion Criteria: Complicated diseases and medical history: Has had other malignant tumors within 5 years or currently has other malignant tumors; Have a variety of factors that affect oral medication (such as inability to swallow); Current history of serious lung disease such as interstitial pneumonia； Severe infections common terminology criteria for adverse events (≥CTCAE (common terminology criteria for adverse events) 2 grade) that were active or uncontrolled before the study treatment started (Except hair loss and hemoglobin)； Known allergy to aromatase inhibitors, tamoxifen, TQB3616/ placebo, or any excipients; There was a history of live attenuated vaccine vaccination within 28 days prior to randomization or live attenuated vaccine vaccination was planned during the study period; Participated in clinical trials of other antitumor agents within 4 weeks prior to randomization； The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of study participation or interfere with the study results, as well as subjects who are deemed unsuitable for study participation for other reasons by the investigator.
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, Doctor
Phone
+86 13501028690
Email
xubinghe@medmail.com.cn
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
300020
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Liu, Doctor
Phone
+86 18922182851
Email
liuqiang_sysu@163.com
Facility Name
Suining Central Hospital
City
Suining
State/Province
Sichuan
ZIP/Postal Code
629099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Yang, Master
Phone
+86 18008258079
Email
snsyhw@163.com

12. IPD Sharing Statement

Learn more about this trial

Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

We'll reach out to this number within 24 hrs